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FDA Device recall Z-1806-2014

RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy

On 2014-06-25 the FDA classified a Class II recall of RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy by Raysearch Laboratories Ab, citing this notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of an ROI can b….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1806-2014
ClassificationClass II
Statusterminated
Initiated2014-04-25
Published2014-06-25
Last updated2026-09-13 11:53 UTC
CompanyRaysearch Laboratories Ab
DistributionUS

Product

RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.

Reason

This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of an ROI can be wrong. This affects all dose-volume properties for such ROIs, including DVH, dose statistics, clinical goals and constraints or objective functions. Furthermore, if material override ROIs are used, or if the external is not represented by contours, the bug can trigger an error in the 3D dose distribution.

Identifiers

code_infoSoftware version 4.0.3.4

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1806-2014%22

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